MAUDE Adverse Event Report: NIPRO CORPORATION (ODT) NIPRO CELLENTIA-H; DIALYZER

Model Number	DD+CT19H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
1 patient/ 3 occurrences with the same lot # reported.Patient lost blood with the 1st occurrence.The 2nd and 3rd occurrence occurred prior to initiating treatment, the machine kept alarming for air.On the 3rd occurrence staff changed the dialyzer with a different lot # and treatment was completed without complications.Additional information received 03/02/2021: priming conditions - they prime with a bfr of 100 and flushed the dialyzer with at least a l of saline.Dialysis conditions - bfr 400, dfr - 800, treatment time 4 hrs and no heparin.Brand/manufacturer name & models of devices used together with dialyzer - gambro machine and lines.How much blood did the patient lost due to changing the dialyzer - 300 ml.Was any medical actions taken- none as their hgb (as claimed when they rechecked) was stable.Where did the bubbles generate - middle to top portion of the dialyzer.
Event or Problem Description
1 patient/ 3 occurrences with the same lot # reported.Patient lost blood with the 1st occurrence.The 2nd and 3rd occurrence occurred prior to initiating treatment, the machine kept alarming for air.On the 3rd occurrence staff changed the dialyzer with a different lot # and treatment was completed without complications.Additional information received 03/02/2021: 1.Priming conditions - they prime with a bfr of 100 and flushed the dialyzer with at least a l of saline.2.Dialysis conditions - bfr 400, dfr - 800, treatment time 4 hrs and no heparin.3.Brand/manufacturer name & models of devices used together with dialyzer - gambro machine and lines.4.How much blood did the patient lost due to changing the dialyzer - 300 ml.5.Was any medical actions taken- none as their hgb (as claimed when they rechecked) was stable.6.Where did the bubbles generate - middle to top portion of the dialyzer.

• Brand Name: NIPRO CELLENTIA-H
• Common Device Name: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• MDR Report Key: 11558883
• Report Number: 9610987-2021-00002
• Device Sequence Number: 19957548
• Product Code: KDI
• UDI-Device Identifier: 40383790004402
• UDI-Public: 40383790004402
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K160444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: DD+CT19H
• Device Lot Number: 20H03D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention